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Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and transporters in vivo. It consists of the administration of probe substances metabolised by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the determination of a metabolic ratio or the evaluation of the plasmatic or urinary concentrations of the probe substances. The administration of a cocktail containing several probe substances allows the simultaneous evaluation of the activity of several cytochromes and P-gp in a single test.

The aim of this project is the validation of a phenotyping cocktail of low dose probe drugs for the assessment of cytochrome P450 and P-gp activities by simple capillary blood sampling and dried blood spot (DBS) analysis. The cocktail consists of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.

The modulation of the activity of cytochromes or P-gp will be evaluated by the administration of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin) of the metabolic pathways or the P-gp mediated transport.

Oral intake of rifampicin (600 mg per day during 7 days) before oral intake of the cocktail probe drugs

Drug: Cocktail probe drugs

Other Names:

Oral intake of the cocktail probe drugs :

bupropion 25 mg

flurbiprofen 25 mg

omeprazole 5 mg

dextromethorphan 5 mg

midazolam 1 mg

fexofenadine 25mg

Caffeine (a cup of coffee)

Experimental: Probe cocktail alone

Oral intake of the cocktail probe drugs :

bupropion 25 mg

flurbiprofen 25 mg

omeprazole 5 mg

dextromethorphan 5 mg

midazolam 1 mg

fexofenadine 25mg

Caffeine (a cup of coffee)

Drug: Cocktail probe drugs

Other Names:

Oral intake of the cocktail probe drugs :

bupropion 25 mg

flurbiprofen 25 mg

omeprazole 5 mg

dextromethorphan 5 mg

midazolam 1 mg

fexofenadine 25mg

Caffeine (a cup of coffee)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Healthy male volunteers aged from 18 to 60 years

BMI between 18 and 25

Understanding of French language and able to give a written inform consent.